Device recall: Alere iScreen Dx Urine Drug Screen Card
Class III FDA enforcement event 79549. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Antidepressants (TCA) as one of the 10 drug analytes included in the kit box.
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
Ameditech Inc started this device recall on 15 Dec 2017. The firm address in the FDA record is in San Diego, CA. FDA put the recall in Class III. FDA event 79549 has 1 product record. The first FDA enforcement report date is 9 May 2018. The record gives the status Terminated, with the termination date 11 Feb 2019.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Distributed domestically to AZ, FL, IL, ND, NV, PA, TN, TX, VA.
Recalling firm
Ameditech Inc, San Diego, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1542-2018 | Alere iScreen Dx Urine Drug Screen Card | 828 kits (20,700 devices) | Class III | Terminated | 9 May 2018 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class III: The lowest of the three FDA recall classes.
The event in context
- Device events that started in 2017
- 1,091
- Share of these events in Class III
- 4%
- Product records in this event
- 1Median of the firm: 3
- Events of the firm on the register
- 8
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 18 Aug 2020 | Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/ "Alere iScreen" Dx Single Dip Ca | Device | Class II | 23 |
| 15 Feb 2019 | QuickTox 5 Panel Drug Screen DipCard | Device | Class III | 1 |
| 30 Sep 2017 | Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is an in vitro diagnostic test for the rapid detect | Device | Class III | 1 |
| 26 Jun 2017 | Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 I | Device | Class III | 1 |
| 16 Nov 2015 | 1 Step 12 Panel Cup, Item No. NBCA-12M-W | Device | Class III | 59 |
| 20 Oct 2015 | 1 Step 12 Panel Cup, Item No. NBCA-12M-W These Drugs of Abuse Tests are one-step immunoassays for the qualitative detect | Device | Class II | 20 |
| 23 Sep 2014 | ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoa | Device | Class II | 3 |
Official channels
- FDA enforcement report Z-1542-2018The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 79549. https://recallregister.com/fda/iii/79549/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Distributed domestically to AZ, FL, IL, ND, NV, PA, TN, TX, VA.
- What quantity of product is in FDA event 79549?
- The FDA record gives this quantity:
828 kits (20,700 devices)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2017 have the same class?
- 4% of the 1,091 device events that started in 2017 are in Class III.